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Completed

NCT Number: NCT05382026

Milk Versus a Pea-based Beverage for Bone and Muscle Health in Young Athletes

Canada's Food Guide places an increased emphasis on plant-based proteins; however, Canadians who consume a plant-based diet may be compromised because of intake of lower-quality protein. Consumption of high-quality protein is important during growth and development, especially in highly active individuals. The study will compare milk (i.e. high quality protein) to a pea-based beverage (i.e. lower quality plant-based protein) in adolescent boys and girls who are engaged in resistance-training programs as part of their athletic training. One-hundred and fourteen adolescent boys and girls (12-17y of age) will be divided into groups that consume milk, a pea-beverage, or a carbohydrate (sugar) beverage after resistance training sessions performed three times per week for six months. It is predicted that the group consuming milk will have greater increases in muscle mass, strength, and bone density, and greater reductions in fat mass compared to the groups consuming a pea-based or carbohydrate beverages.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

About this study

Milk protein is important especially for very active people and in the context of plant-based diets, which are lower in protein quality. The purpose of the study is to compare the effectiveness of milk supplementation to pea-beverage supplementation during resistance training programs for increasing lean tissue mass in adolescent boys and girls. Secondary and tertiary outcomes include fat mass, bone mineral density, and muscular strength. It is hypothesized that milk supplementation during resistance training will be more effective than plant-based proteins (i.e. pea-beverage) for increasing muscle mass, reducing fat mass, and improving bone mineral outcomes in adolescent boys and girls. One-hundred and fourteen boys and girls (aged 12-17y) who are currently enrolled in resistance training programs (3 times per week for 6 months) as part of their competitive athletic programs will be stratified by sex and maturity status before being randomized to three groups: 1) 1% chocolate milk supplementation; 2) pea-based beverage; 3) carbohydrate beverage (placebo control). Beverages will be consumed during recovery from each resistance training session (i.e. 250 ml immediately after training and 250 ml one hour later to optimize post-exercise protein synthesis) over the six-month intervention. It is anticipated that milk supplementation will be more effective than plant-based protein supplementation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently participating in a resistance-training program 3 times per week
  • Female participants must have reached menarche

Exclusion criteria

  • Have taken any nutritional supplement (e.g., protein, creatine, amino acids) within the past month
  • Currently taking anabolic steroids or oral corticosteroids
  • Allergies to dairy, almonds, cashews, or peas

Treatment and study plan

Nutritional supplementation during a 6 month resistance training program

Dietary Supplement

1% chocolate milk

Primary outcomes

  1. Change in lean tissue mass (kg)

    Time frame: 6 months

    Lean tissue mass measured by dual energy X-ray absorptiometry

Secondary outcomes

  1. Change in fat mass (kg)

    Time frame: 6 months

    Fat mass measured by dual energy X-ray absorptiometry

  2. Change in lumbar spine bone mineral density (g/cm-squared)

    Time frame: 6 months

    Lumbar spine bone mineral density measured by dual energy X-ray absorptiometry

  3. Change in hip bone mineral density (g/cm-squared)

    Time frame: 6 months

    Hip bone mineral density measured by dual energy X-ray absorptiometry

  4. Change in bench press strength (kg)

    Time frame: 6 months

    Bench press strength predicted from resistance lifted for 6-10 repetitions

  5. Change in squat strength (kg)

    Time frame: 6 months

    Squat strength predicted from resistance lifted for 6-10 repetitions

  6. Change in cross-sectional moment of inertia at the hip (cm to the power of 4)

    Time frame: 6 months

    Cross-sectional moment of inertia measured by dual energy X-ray absorptiometry

  7. Change in section modulus at the hip (cm to the power of 3)

    Time frame: 6 months

    Section modulus measured by dual energy X-ray absorptiometry

  8. Change in cross-sectional area at the hip (cm-squared)

    Time frame: 6 months

    Cross-sectional area measured by dual energy X-ray absorptiometry

  9. Change in cortical thickness at the hip (cm)

    Time frame: 6 months

    Cortical thickness measured by dual energy X-ray absorptiometry

  10. Change in buckling ratio at the hip (no units)

    Time frame: 6 months

    Buckling ratio measured by dual energy X-ray absorptiometry

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Milk Versus a Pea-based Beverage for Increasing Muscle Mass and Bone Mineral Density During Resistance Training in Adolescent Boys and Girls

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 19, 2022
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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